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Bioanalytical Lab Capabilities

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Cell-based Assays

Cell-based assays represent a key platform utilized for various applications, such as drug safety assessment, needed as part of immunogenicity studies. PPD® Laboratories’ bioanalytical lab has been providing cell-based assays services since 2007.

The bioanalytical lab has a dedicated team of research scientists experienced in cell culture technologies, cell-based assay development and validation, cell-line engineering, microbiology, virology and molecular biology.

The bioanalytical lab’s cell-based assay experience involves the transfer of more than 80 cell-based assays across a wide range of applications including:

Drug-specific NAb assays (including biosimilars)

Biomarkers

Toxin neutralization assay (TNA)

Virus-specific NAb assays

Our service offering includes:

Comprehensive assay transfer capabilities

CLIA validation of NAb assays

Sample analysis for studies in excess of 1,500 samples

Various end points for early events, for example receptor phosphorylation (ECL), cellular proliferation (cATP, cAMP) and cell signaling pathways (STAT3,SMAD)

Numerous end points for late events consists of cytokine production/detection and reporter gene products (fluorescence)

Key instrumentation:

MSD® Sector® S 600 reader

BioTek Cytation™ reader

Beckman Coulter Vi-CELL™ analyzer

Biosafety cabinets

CO2 incubators

In addition to supporting bioanalytical studies for various types of pharmaceuticals, cell-based assays are an integral part of vaccine development.

Chromatography/Mass Spectrometry

PPD® Laboratories’ bioanalytical lab offers substantial capacity and expertise in the increasingly sophisticated field of chromatography. We have applied LC-MS/MS to compounds that range from small molecules to antibody-drug conjugates (ADCs) with measurement in biological fluids and tissues. We utilize the most advanced automated sample cleanup techniques for rapid sample analysis and employ stable isotope internal standards for highly precise quantitation. Our extensive scientific and technical expertise includes:

Highly diverse range of analytes from small molecules to complex biologics

From fit-for-purpose assays to projects that require GCLP-, GLP- or CLIA-compliant assays we have the technology platforms, the clinical expertise and the collaborative and flexible mindset needed to develop customized solutions for our clients.

We have a dedicated team of scientists at the bioanalytical lab and many cross-trained scientists across the various central lab locations. Research and development for flow cytometry assays is performed in our Richmond, Virginia, location, where our scientists have more than 25 years of combined experience.

Our service offering includes:

Assay development and validation under CAP/CLIA, GLP and/or GCLP regulations

Molecular Genomics

PPD Laboratories has custom-built a spacious, cutting-edge molecular genomics suite staffed with a dedicated team of molecular biologists. The suite of labs is designed with the appropriate engineering and procedural controls to minimize the risk of reagent and sample contamination. Our capabilities include assay development, qualification, validation and sample analysis services in the following areas: